Webinar Details

Date	Tuesday, November 10, 2026
Time	2:00 to 3:00 PM ET (11:00 AM PT / 19:00 UTC / 20:00 CET)
Format	Live online webinar (GoToWebinar)
Hosts	Amin Wasserman Gurnani (AWG) and Hansem Global
Registration	https://register.gotowebinar.com/register/3566545699040380768

Why Attend

The U.S. remains one of the most competitive and tightly regulated markets for medical devices. Even with a high-quality product, many companies face costly delays because of gaps in documentation or a misunderstanding of regulatory requirements. Domestic and foreign manufacturers alike must meet the same set of FDA requirements, and labeling is part of nearly every one of them.

This session explains when and how the key requirements apply, offers practical guidance on timelines and enforcement risk, and shares strategies for minimizing regulatory scrutiny.

What We Will Cover

FDA regulatory requirements (AWG)

• Medical device premarket submissions, including 510(k)
• Quality Management System Regulation (QMSR)
• Establishment registration and device listing
• Medical device reporting

Building IFUs for safety, usability, and regulatory readiness (Hansem Global)
Before a manufacturer asks which FDA rules apply to its IFU, it should ask a more basic question: does the document work as an instruction for use? Hansem Global will cover the principles that apply to user information in every industry, including user-centered IFU design based on IEC/IEEE 82079-1 and safety messaging based on ANSI Z535.6. The session will then show how device-specific FDA requirements, such as 21 CFR Part 801 labeling and UDI, are built into the IFU.

Who Should Attend
The program is designed for small and mid-sized medical device companies that want a clear, practical overview of FDA compliance for a U.S. product launch. It will be especially useful for:

• Companies preparing for their first U.S. launch or expanding into the U.S. market
• Regulatory affairs and quality professionals
• Technical documentation and labeling teams
• Executives who want to pressure-test their current U.S. market strategy

Manufacturers based outside the U.S., including companies in Asia and Europe, will find the session useful for understanding how FDA requirements affect both their submissions and their documentation.

Presenters

Neil O’Flaherty | Partner, Amin Wasserman Gurnani
Neil has more than 36 years of legal experience representing medical device companies. He advises clients on Class I, II, and III devices at every stage of the premarket and commercial lifecycle, from multinational firms to start-ups.

Brian Cho | Managing Director, PMP, Hansem Global
Brian helps medical device companies prepare clear, accurate documentation that is ready for localization for the U.S. and international markets. He brings a practical perspective on how documentation quality and localization align with regulatory requirements during global product launches.

Register Now
Space is limited. Reserve your spot through the link below.
Register: https://register.gotowebinar.com/register/3566545699040380768
Event page on the AWG website: https://awglaw.com/events/how-to-get-it-right-legally-launch-a-medical-device-in-the-u-s/
If you are planning IFU development or translation and localization for your medical device, please get in touch. Our specialists for each service will be glad to walk you through the details.